Injuries to body conduits, particularly to the vascular system, are commonplace. These injuries are frequently life-threatening, exsanguination often occurring as a result of such injuries. Blood vessels may be lacerated or may be completely transected, including incidents involving amputations of limbs. The use of endoprostheses such as stent grafts to temporarily or permanently repair such injuries offers the potential to considerably reduce the loss of blood and risk of loss of life. These devices may be quickly implanted under direct visualization at the site of such injuries, halting or substantially reducing loss of blood and maintaining perfusion of an affected limb. This may be accomplished during emergency room procedures and may also be possible at the site of an accident by qualified emergency personnel.
Implantation of endoprostheses including stent-grafts under direct visualization at the site of surgically-created traumas is known. U.S. Pat. No. 3,657,744 to Ersek describes the implantation of a bifurcated vascular graft into a surgically-created transection of the aorta wherein the graft ends are secured within the blood vessel by individually deployed balloon expanded stents.
Similarly, U.S. Pat. Nos. 5,591,226 and 5,755,775 to Trerotola et al. teach the use of non-bifurcated stent-grafts for the repair of transected blood vessels under direct visualization wherein cannula devices (“vascular access means”) are first inserted into each of the exposed, transected ends of the blood vessel. The two ends of the self-expanding stent-graft are retained in a compacted small diameter by individual, longitudinally splittable retaining sheaths. The small compacted diameter of the stent-graft allows for individual insertion of the ends of the device into the cannula devices within the exposed ends of the transected vessel. After insertion into the ends of the blood vessel, each end of the stent-graft is separately deployed from its initial, compacted diameter to its larger, final diameter by longitudinal splitting of the cannula devices and the retaining sheaths; these components are simultaneously removed from the transected end of the blood vessel while they are being longitudinally split. The splitting of the retaining sheath is accomplished beginning from the end of the sheath closest to the middle of the length of the stent-graft and proceeding toward the end of the stent-graft, thereby allowing the stent-graft to deploy to its larger, full diameter in the same direction as the splitting of the retaining sheath. Causing the deployment of the stent-graft to occur from the middle toward the ends is undesirable as the ends of the graft may be pushed out of the ends of the blood vessel as the diameter of the stent-graft increased in that direction.
U.S. Pat. No. 6,019,788 to Butters et al. describes an arteriovenous shunt graft having y-shaped ends that are insertable under direct visualization into transected blood vessels and deployable from the smaller diameter at which they were inserted to a larger diameter that secures them with the transected ends of the blood vessel. U.S. Pat. Nos. 5,755,778 and 5,921,995 to Kleshinski teach tubular stent-grafts for use as anastomotic devices that are inserted into transected ends of blood vessels and deployed.
Percutaneously inserted stent-grafts have also been used for the repair of traumatic injuries. For example, a paper by Dr. Vinay Kumar (“Endovascular treatment of penetrating injury of axillary vein with Viabahn endoprosthesis,” Journal of Vascular Surgery, December 2004, pp. 1243-1244) describes repairing a knife wound of an axillary vein by delivering the endoprosthesis to the injured site via the basilic vein. Deployment of the device at the injury site resulted in immediate control of hemorrhage.
WO99/65420 describes a restraining cover for retaining a self-expandable endoprosthesis in its compacted, small diameter state prior to deployment. The cover has opposing ends that are separately releasable (allowing separate deployment of the two opposing ends of the contained endoprosthesis), with deployment of the individual ends of the contained endoprosthesis initiated by the application of tension to separate rip cords that release from the center of the length of the cover. WO98/27894 teaches a stent-graft that is deployable beginning from the middle of the length of the device and progressing simultaneously toward both ends.
U.S. Pat. No. 3,221,746 to Noble teaches the use of an anastomotic connector useful for the repair of severed tubular canal members, regardless of whether the severing is the result of accident, illness or surgery. U.S. Pat. No. 4,721,109 to Healey describes a temporary anastomotic device for maintaining blood flow in damaged blood vessels. Greenhalgh, in US Patent Application Publication 2002/0087176 discusses a tubular support intended as an anastomosis device for veins and arteries, the device comprising a tubular braided structure of elastic filamentary fibers optionally including an elastomeric membrane covering over the tubular braided structure.
These various devices of the prior art have thus far been unsuccessful in the field of emergency repair of body conduits. There remains a need for a quickly-effective device that reduces the risk of loss of substantial amounts of blood and the associated risk of loss of limb or life.